October 15, 2025DrugsFDA
GenoGenix LLC recalls Ascorbic Acid (Vitamin C) for Injection, Preservative Free, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd
Hazard: Lack of Assurance of Sterility
October 15, 2025DrugsFDA
GenoGenix LLC recalls Amino Blend for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431
Hazard: Lack of Assurance of Sterility
October 15, 2025DrugsFDA
GenoGenix LLC recalls Alpha Lipoic Acid for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL
Hazard: Lack of Assurance of Sterility
October 15, 2025DrugsFDA
Acella Pharmaceuticals, LLC recalls Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distributed by: Acella Pharmaceuticals, LLC, Alphar
Hazard: Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
October 15, 2025DrugsFDA
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalls Major ChlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Dist
Hazard: CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
October 15, 2025DrugsFDA
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalls Major ChlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Dist
Hazard: CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
October 15, 2025DrugsFDA
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalls Major ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 Tablets, (10x10) blister package, Rx Only, Packaged and Dist
Hazard: CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
October 15, 2025DrugsFDA
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalls Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distr
Hazard: CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
October 15, 2025DrugsFDA
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalls Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 50 Tablets (5x10) blister package, Rx Only, Packaged and Distrib
Hazard: CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
October 15, 2025DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 25 x 10 mL Multiple-Dose Vials, For Intravenous or Int
Hazard: Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
October 15, 2025DrugsFDA
AvKARE recalls Norgestimate and Ethinyl Estradiol Tablets, USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg, 3 Units, 3x2
Hazard: Failed Content Uniformity Specifications
October 15, 2025DrugsFDA
ACCORD HEALTHCARE, INC. recalls Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, Rx Only, Manufactured for Accord Healthcare
Hazard: Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range.
October 15, 2025DrugsFDA
Acuity Specialty Products, Inc. recalls AFCO, Hand Sanitizer (Isopropyl Alcohol-Based, Product 5515), Manufactured by: AFCO, 550 Development Avenue, Chambersbur
Hazard: cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded.
October 15, 2025DrugsFDA
Acuity Specialty Products, Inc. recalls Wyandotte, Sanifect E3, Hand Sanitizer (Ethanol-Based, Product 5511), Ethyl Alcohol 60.1%, Manufacture By: AFCO, 550 Dev
Hazard: cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded.
October 15, 2025DrugsFDA
RC Outsourcing, LLC recalls Bevacizumab 1.75 mg/0.07 mL - 0.25 mL syringe, Intravitreal, 0.07 mL Total Volume, Rx Only, Hospital/Office Use Only, Re
Hazard: Lack of assurance of sterility.
October 8, 2025DrugsFDA
Apotex Corp. recalls Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, O
Hazard: Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
October 8, 2025DrugsFDA
Apotex Corp. recalls Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL and b) 10 mL, Rx Only, Sterile, Manufacture
Hazard: Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
October 8, 2025DrugsFDA
Amerisource Health Services LLC recalls Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton (3x10 unit dose cards), Rx Only, American Heal
Hazard: Failed Dissolution Specifications.
October 8, 2025DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Dist
Hazard: Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
October 8, 2025DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Di
Hazard: Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
October 1, 2025DrugsFDA
Medline Industries, LP recalls READYPREP PVP, Povidone-Iodine 10% Solution, Topical Antiseptic, Not Sterile, 1 Gallon (3.78 L) per bottle, Manufactured
Hazard: Subpotent drug
October 1, 2025DrugsFDA
Granules Pharmaceuticals Inc. recalls Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Exte
Hazard: Failed Impurities/Degradation Specifications:
October 1, 2025DrugsFDA
Granules Pharmaceuticals Inc. recalls Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Exte
Hazard: Failed Impurities/Degradation Specifications:
October 1, 2025DrugsFDA
Granules Pharmaceuticals Inc. recalls Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Exte
Hazard: Failed Impurities/Degradation Specifications:
October 1, 2025DrugsFDA
Granules Pharmaceuticals Inc. recalls Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Exte
Hazard: Failed Impurities/Degradation Specifications:
October 1, 2025DrugsFDA
Granules Pharmaceuticals Inc. recalls Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Exte
Hazard: Failed Impurities/Degradation Specifications:
October 1, 2025DrugsFDA
Private Label Skin Care Inc. recalls edunn clarity, BP Treatment Cleanser 10% (Benzoyl Peroxide 10%), 7 oz (201g) Uptown Medi Spa, Phoenix, AZ.
Hazard: Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
October 1, 2025DrugsFDA
Private Label Skin Care Inc. recalls Micronized BPO Gel Cleanser 10% (Benzoyl Peroxide 10%) Pantea MD , 7 oz (201 g), University Skin Institute, 650 Universi
Hazard: Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
October 1, 2025DrugsFDA
Private Label Skin Care Inc. recalls mel rx Skin, NO DRAMA Benzoyl Peroxide 10% Acne Treatment, 7 oz, 201 g Mel Skin Rx Beverly Hills, CA 90210
Hazard: Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
October 1, 2025DrugsFDA
Private Label Skin Care Inc. recalls Torrey Pines Dermatology & Laser Center Benzaderm BPO Cleanser 10% (Benzoyl Peroxide 10%) 7oz (201 g), Torreypines.com
Hazard: Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.